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Completed

NCT Number: NCT00278889

Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of colon or rectal cancer,
  • Received prior systemic therapy for cancer,
  • Cancer must have progressed during or after first treatment

Exclusion criteria

  • Prior treatment with a VEGF inhibitor,
  • Poorly controlled hypertension

Treatment and study plan

AZD2171

Drug

oral tablet

Other names: cediranib, RECENTIN™

5-fluorouracil

Drug

intravenous infusion

Other names: 5-FU

Leucovorin

Drug

intravenous infusion

Oxaliplatin

Drug

intravenous infusion

Other names: Eloxatin®

Bevacizumab

Drug

intravenous infusion

Other names: Avastin®

Primary outcomes

  1. Progression Free Survival

    Time frame: Randomisation to data cut-off date of November 2007

    Number of months from randomisation to the earlier date of objective progression or death

Secondary outcomes

  1. Objective Response Rate

    Time frame: Randomisation to data cut-off date of November 2007

    Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.

  2. Overall Survival

    Time frame: Randomisation to data cut-off date of 30 January 2009

    Number of months from randomisation to the date of death from any cause

  3. Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)

    Time frame: Randomisation to data cut-off date of November 2007

    Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires

  4. QOL: Time to Worsening of Treatment-free Survival (TFS)

    Time frame: Randomisation to data cut-off date of November 2007

    Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires

  5. QOL: Time to Worsening of Clear Cell Sarcoma (CCS)

    Time frame: Randomisation to data cut-off date of November 2007

    Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

  6. QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)

    Time frame: Randomisation to data cut-off date of November 2007

    Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer

Acronym: HORIZON I

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Jan 19, 2006
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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